Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada
Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada
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DOI：
10.1186/s12885-020-06798-1
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发表时间：
2020-04-15
期刊：
影响因子：
3.8
通讯作者：
Chan, Kelvin K. W.
中科院分区：
文献类型：
--
作者：
Dai, Wei Fang;Beca, Jaclyn M.;Chan, Kelvin K. W.
对于新的癌症治疗方法，临床实践中的有效性并不总是与临床疗效结果一致。因此，了解一种治疗方法在现实世界中的有效性是很重要的。我们研究了二线伊匹单抗与非伊匹单抗治疗（化疗或靶向治疗）在现实世界中基于人群的比较有效性。方法：我们选取了一组自2005年4月以来在加拿大安大略省接受全身治疗的晚期黑色素瘤患者。从省级药物数据库和安大略省癌症登记处确定患者，这些患者在2012年至2015年期间接受了二线伊匹单抗治疗（已治疗）或2012年之前接受了二线非伊匹单抗治疗（历史对照）。选择历史对照，以便与关键试验结果进行最直接的比较。该队列与管理数据库相关联，以确定基线特征和结果。Kaplan-Meier曲线和多变量Cox回归模型评估总生存期（OS）。观察到的潜在混杂因素使用治疗加权逆概率（IPTW）进行校正。我们确定了329例接受二线治疗的转移性黑色素瘤（MM）患者（189例接受治疗，140例为对照组）。与历史对照组相比，接受二线伊匹单抗治疗的患者年龄更大（61.7岁vs 55.2岁）。伊匹单抗组和对照组的中位OS分别为6.9个月（95% CI: 5.4-8.3）和4.95个月（4.3-6.0）。伊匹单抗1年、2年和3年的粗OS概率分别为34.3%（27-41%）、20.6%（15-27%）和15.2%(9.6-21%)，对照组为17.1%（11-23%）、7.1%（2.9-11%）和4.7%（1.2-8.2%）。Ipilimumab与改善的OS相关(IPTW HR=0.62; 95% CI: 0.49-0.78
BackgroundFor novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment's real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments).MethodsWe used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW).ResultsWe identified 329 patients with metastatic melanoma (MM) who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7years vs 55.2years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27-41%), 20.6% (15-27%), and 15.2% (9.6-21%) for ipilimumab and 17.1% (11-23%), 7.1% (2.9-11%), and 4.7% (1.2-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR=0.62; 95% CI: 0.49-0.78; p